Sterile filtration of a multi-serotype glycoconjugate vaccine drug product

Zhuoshi Du, Kanwaldeep Gill, Vishal Toprani, Andrew L. Zydney

Research output: Contribution to journalArticlepeer-review

1 Scopus citations

Abstract

Glycoconjugate vaccines consisting of multiple serotypes of the bacterial capsular polysaccharide can provide strong protection against infection by significant pathogens. Previous studies of the sterile filtration behavior of these glycoconjugates have been limited to experiments with individual serotypes even though the formulated vaccines contain several different serotypes to provide broad immunization. The objective of this study was to explore the fouling behavior of a glycoconjugate vaccine drug product consisting of four different polysaccharide serotypes. Sterile filtration data were obtained with 0.22 µm Durapore® membranes at both constant flux and constant pressure for both the individual serotypes and the drug product containing multiple serotypes. Fouled membranes were examined by confocal microscopy, demonstrating that all four serotypes deposit in a narrow band near the filter inlet. The different ionic composition of the formulation buffer (compared to the buffers used with the drug substance) had a large effect on the fouling behavior. In addition, the fouling resistance associated with the drug product was greater than the sum of the resistances of the individual serotypes. These results provide important insights into the sterile filtration behavior of these multivalent glycoconjugate vaccines.

Original languageEnglish (US)
Pages (from-to)1316-1322
Number of pages7
JournalBiotechnology and bioengineering
Volume120
Issue number5
DOIs
StatePublished - May 2023

All Science Journal Classification (ASJC) codes

  • Biotechnology
  • Bioengineering
  • Applied Microbiology and Biotechnology

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